L 320/18
EN
Official Journal of the European Union
3.12.2011
COMMISSION REGULATION (EU) No 1259/2011
of 2 December 2011
amending Regulation (EC) No 1881/2006 as regards maximum levels for dioxins, dioxin-like PCBs
and non dioxin-like PCBs in foodstuffs
(Text with EEA relevance)
(EFSA) scientific report ‘Results of the monitoring of
dioxin levels in food and feed’ (3). Therefore, it is appro­
priate to review the maximum levels of PCBs taking into
account these new data.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European
Union,
(5)
The Scientific Panel on Contaminants in the Food Chain
of the EFSA on a request from the Commission has
adopted an opinion on the presence of NDL-PCBs in
feed and food (4).
(6)
The sum of the six marker or indicator PCBs (PCB 28,
52, 101, 138, 153 and 180) comprises about half of the
amount of total NDL-PCB present in feed and food. That
sum is considered as an appropriate marker for
occurrence and human exposure to NDL-PCB and
therefore should be set as a maximum level.
(7)
Maximum levels have been established taking into
account recent occurrence data compiled in the EFSA
scientific report ‘Results of the monitoring of non
dioxin-like PCBs in food and feed’ (5). Although it is
possible to achieve lower limits of quantification (LOQ),
it can be observed that a considerable number of labora­
tories apply an LOQ of 1 μg/kg fat or even 2 μg/kg fat.
Expressing the analytical result as an upperbound level
would result in some cases in a level close to the
maximum level if very strict maximum levels would be
established, even if no PCBs have been quantified. It was
also acknowledged that for certain food categories the
data were not very extensive. Therefore, it would be
appropriate to review the maximum levels in 3 years
time, based upon a more extensive database obtained
with a method of analysis with sufficient sensitivity for
quantifying low levels.
(8)
Derogations have been granted to Finland and Sweden to
place on the market fish originating in the Baltic region
and intended for consumption in their territory with
dioxin levels higher than the maximum levels established
for dioxins and the sum of dioxins and DL-PCBs in fish.
Those Member States have fulfilled the conditions as
regards the provision of information to consumers on
dietary recommendations. Every year they communicate
to the Commission the results of their monitoring of the
levels of dioxins in fish from the Baltic region and the
measures to reduce human exposure to dioxins from the
Baltic region.
Having regard to Council Regulation (EEC) No 315/93 of
8 February 1993 laying down Community procedures for
contaminants in food (1), and in particular Article 2(3) thereof,
Whereas:
(1)
Commission Regulation (EC) No 1881/2006 of
19 December 2006 setting maximum levels for certain
contaminants in foodstuffs (2) sets maximum levels for
dioxins and dioxin-like PCBs in a range of foodstuffs.
(2)
Dioxins belong to a group of 75 polychlorinated
dibenzo-p-dioxin (PCDD) congeners and 135 polychlor­
inated dibenzofuran (PCDF) congeners, of which 17 are
of toxicological concern. Polychlorinated biphenyls
(PCBs) are a group of 209 different congeners which
can be divided into two groups according to their toxi­
cological properties: 12 congeners exhibit toxicological
properties similar to dioxins and are therefore often
referred to as ‘dioxin-like PCBs’ (DL-PCB). The other
PCBs do not exhibit dioxin-like toxicity but have a
different toxicological profile and are referred to as
‘non dioxin-like PCB’ (NDL-PCB).
(3)
Each congener of dioxins or DL-PCBs exhibits a different
level of toxicity. In order to be able to sum up the
toxicity of these different congeners, the concept of
toxic equivalency factors (TEFs) was introduced to
facilitate risk assessment and regulatory control. As a
result the analytical results relating to all the individual
dioxin and dioxin-like PCB congeners of toxicological
concern are expressed in terms of a quantifiable unit,
namely the TCDD toxic equivalent (TEQ).
(4)
The World Health Organisation (WHO) held an expert
workshop on 28 to 30 June 2005 concerning the TEF
values, agreed by WHO in 1998. A number of TEF
values were changed, notably for PCBs, octachlorinated
congeners and pentachlorinated furans. The data on the
effect of the new TEF values and the recent occurrence
are compiled in the European Food Safety Authority’s
(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 364, 20.12.2006, p. 5.
(3) EFSA Journal 2010; 8(3):1385, http://www.efsa.europa.eu/en/
efsajournal/doc/1385.pdf
(4) EFSA Journal (2005) 284, p. 1, http://www.efsa.europa.eu/en/
efsajournal/doc/284.pdf
(5) EFSA Journal 2010; 8(7):1701, http://www.efsa.europa.eu/en/
efsajournal/doc/1701.pdf
3.12.2011
EN
Official Journal of the European Union
(9)
On the basis of the results of monitoring of levels of
dioxins and DL-PCBs carried out by Finland and Sweden,
the derogation granted could be limited to certain fish
species. Given the persistent presence of dioxins and
PCBs in the environment and consequently in fish it is
appropriate to grant this derogation without a time limit.
(10)
As regards wild caught salmon, Latvia has requested a
similar derogation as that granted to Finland and Sweden.
To that end, Latvia has demonstrated that human
exposure to dioxins and DL-PCBs in its territory is not
higher than the highest average level in any of the
Member States and that it has a system in place to
ensure that consumers are fully informed of dietary
recommendations with regard to restrictions on the
consumption of fish from the Baltic region by identified
vulnerable sections of the population in order to avoid
potential health risks. Furthermore, monitoring of the
levels of dioxins and DL-PCBs in fish from the Baltic
region should be carried out and the results and
measures that have been taken to reduce human
exposure to dioxins and DL-PCBs from fish from the
Baltic region should be reported to the Commission.
The necessary measures have been put in place
ensuring that fish and fish products not complying
with EU maximum levels for PCBs are not marketed in
other Member States.
(11)
(12)
(13)
Given that the contamination pattern of NDL-PCBs in
fish from the Baltic region show similarities with the
contamination of dioxins and DL-PCBs and given that
also NDL-PCBs are very persistent in the environment,
it is appropriate to grant a similar derogation as regards
the presence of NDL-PCBs as for dioxins and DL-PCBs in
fish from the Baltic region.
EFSA has been requested to provide scientific opinion as
regards the presence of dioxins and dioxin-like PCBs in
sheep and deer liver and the appropriateness to establish
maximum levels for dioxins and PCBs in liver and
derived products on product basis rather than on a fat
basis, as is currently the case. Therefore, the provisions
on liver and derived products should be reviewed in
particular the provisions as regards sheep and deer liver
once the EFSA opinion is available. In the meantime it is
appropriate to set the maximum level for dioxins and
PCBs on a fat basis.
Foods with less than 1 % fat were until now excluded
from the maximum level for dioxins and DL-PCBs, given
that those foods are generally minor contributors to the
human exposure. However, there have been cases with
food containing less than 1 % fat but with very high
levels of dioxins and DL-PCBs in the fat. Therefore, it
is appropriate to apply the maximum level to such
foods, but on a product basis. Taking into account that
a maximum level is established on product basis for
certain low fat containing foods, it is appropriate to
apply a maximum level on product basis for foods
containing less than 2 % fat.
L 320/19
(14)
In the light of the monitoring data for dioxins and DLPCBs in foods for infants and young children it is appro­
priate to set specific lower maximum levels for dioxins
and DL-PCBs in foods for infants and young children.
The Federal Institute for Risk Assessment from Germany
has addressed to EFSA a specific request to assess the risk
for infants and young children of the presence of dioxins
and dioxin-like PCBs in foods for infants and young
children. Therefore, the provisions on foods for infants
and young children should be reviewed once the EFSA
opinion is available.
(15)
The measures provided for in this Regulation are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health and
neither the European Parliament nor the Council have
opposed them,
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 1881/2006 is amended as follows:
(1) Article 7 is amended as follows:
(a) The title ‘Temporary derogations’ is replaced by
‘Derogations’;
(b) paragraph 4 is replaced by the following:
‘4.
By way of derogation from Article 1, Finland,
Sweden and Latvia may authorise the placing on their
market of wild caught salmon (Salmo salar) and products
thereof originating in the Baltic region and intended for
consumption in their territory with levels of dioxins
and/or dioxin-like PCBs and/or non-dioxin-like PCBs
higher than those set out in point 5.3 of the Annex,
provided that a system is in place to ensure that
consumers are fully informed of the dietary recommen­
dations with regard to the restrictions on the
consumption of wild caught salmon from the Baltic
region and products thereof by identified vulnerable
sections of the population in order to avoid potential
health risks.
Finland, Sweden and Latvia shall continue to apply the
necessary measures to ensure that wild caught salmon
and products thereof not complying with point 5.3 of
the Annex are not marketed in other Member States.
Finland, Sweden and Latvia will report yearly to the
Commission the measures they have taken to effectively
inform the identified vulnerable sections of the popu­
lation of the dietary recommendations and to ensure
that wild caught salmon and products thereof not
compliant with the maximum levels is not marketed
in other Member States. They shall furthermore
provide evidence of the effectiveness of these measures.’;
L 320/20
EN
Official Journal of the European Union
(c) the following paragraph 5 is added:
‘5.
By way of derogation from Article 1, Finland and
Sweden may authorise the placing on their market of
wild caught herring larger than 17 cm (Clupea harengus),
wild caught char (Salvelinus spp.), wild caught river
lamprey (Lampetra fluviatilis) and wild caught trout
(Salmo trutta) and products thereof originating in the
Baltic region and intended for consumption in their
territory with levels of dioxins and/or dioxin-like PCBs
and/or non dioxin-like PCBs higher than those set out in
point 5.3 of the Annex, provided that a system is in
place to ensure that consumers are fully informed of the
dietary recommendations with regard to the restrictions
on the consumption of wild caught herring larger than
17 cm, wild caught char, wild caught river lamprey and
wild caught trout from the Baltic region and products
thereof by identified vulnerable sections of the popu­
lation in order to avoid potential health risks.
Finland and Sweden shall continue to apply the
necessary measures to ensure that wild caught herring
larger than 17 cm, wild caught char, wild caught river
3.12.2011
lamprey and wild caught trout and products thereof not
complying with point 5.3 of the Annex are not
marketed in other Member States.
Finland and Sweden will report yearly to the
Commission the measures they have taken to effectively
inform the identified vulnerable sections of the popu­
lation of the dietary recommendations and to ensure
that fish and products thereof not compliant with the
maximum levels is not marketed in other Member
States. They shall furthermore provide evidence of the
effectiveness of these measures.’;
(2) the Annex is amended in accordance with the Annex to this
Regulation.
Article 2
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 December 2011.
For the Commission
The President
José Manuel BARROSO
EN
3.12.2011
Official Journal of the European Union
L 320/21
ANNEX
Section 5: Dioxins and PCBs of the Annex to Regulation (EC) No 1881/2006 is amended as follows:
(a) Section 5: Dioxins and PCBs is replaced by the following:
‘Section 5: Dioxins and PCBs (31)
Maximum levels
Sum of dioxins
(WHO-PCDD/F-TEQ) (32)
Sum of dioxins and
dioxin-like PCBS
(WHO-PCDD/F-PCB-TEQ) (32)
Sum of PCB28,
PCB52, PCB101,
PCB138, PCB153
and PCB180
(ICES – 6) (32)
— bovine animals and sheep
2,5 pg/g fat (33)
4,0 pg/g fat (33)
40 ng/g fat (33)
— poultry
1,75 pg/g fat (33)
3,0 pg/g fat (33)
40 ng/g fat (33)
— pigs
1,0 pg/g fat (33)
1,25 pg/g fat (33)
40 ng/g fat (33)
5.2
Liver of terrestrial animals referred to
in 5.1 (6), and derived products
thereof,
4,5 pg/g fat (33)
10,0 pg/g fat (33)
40 ng/g fat (33)
5.3
Muscle meat of fish and fishery
products and products thereof (25) (34),
with the exemption of:
3,5 pg/g wet weight
6,5 pg/g wet weight
75 ng/g wet
weight
Foodstuffs
5.1
Meat and meat products (excluding
edible offal) of the following
animals (6):
— wild caught eel
— wild caught fresh water fish, with
the exception of diadromous fish
species caught in fresh water
— fish liver and derived products
— marine oils
The maximum level for crustaceans
applies to muscle meat from
appendages and abdomen (44). In
case of crabs and crab-like crustaceans
(Brachyura and Anomura) it applies to
muscle meat from appendages.
5.4
Muscle meat of wild caught fresh
water fish, with the exception of
diadromous fish species caught in
fresh water, and products thereof (25)
3,5 pg/g wet weight
6,5 pg/g wet weight
125 ng/g wet
weight
5.5
Muscle meat of wild caught eel
(Anguilla anguilla) and products
thereof
3,5 pg/g wet weight
10,0 pg/g wet weight
300 ng/g wet
weight
5.6
Fish liver and derived products thereof
with the exception of marine oils
referred to in point 5.7
—
20,0 pg/g wet
weight (38)
200 ng/g wet
weight (38)
5.7
Marine oils (fish body oil, fish liver oil
and oils of other marine organisms
intended for human consumption)
1,75 pg/g fat
6,0 pg/g fat
200 ng/g fat
5.8
Raw milk (6) and dairy products (6),
including butter fat
2,5 pg/g fat (33)
5,5 pg/g fat (33)
40 ng/g fat (33)
EN
L 320/22
Official Journal of the European Union
3.12.2011
Maximum levels
Sum of dioxins
(WHO-PCDD/F-TEQ) (32)
Sum of dioxins and
dioxin-like PCBS
(WHO-PCDD/F-PCB-TEQ) (32)
Sum of PCB28,
PCB52, PCB101,
PCB138, PCB153
and PCB180
(ICES – 6) (32)
2,5 pg/g fat (33)
5,0 pg/g fat (33)
40 ng/g fat (33)
— bovine animals and sheep
2,5 pg/g fat
4,0 pg/g fat
40 ng/g fat
— poultry
1,75 pg/g fat
3,0 pg/g fat
40 ng/g fat
— pigs
1,0 pg/g fat
1,25 pg/g fat
40 ng/g fat
5.11
Mixed animal fats
1,5 pg/g fat
2,50 pg/g fat
40 ng/g fat
5.12
Vegetable oils and fats
0,75 pg/g fat
1,25 pg/g fat
40 ng/g fat
5.13
Foods for
children (4)
0,1 pg/g wet weight
0,2 pg/g wet weight
1,0 ng/g wet
weight’
Foodstuffs
5.9
Hen eggs and egg products (6)
5.10
Fat of the following animals:
infants
and
young
(b) footnote 31 is replaced by the following:
‘(31) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs),
expressed as World Health Organisation (WHO) toxic equivalent using the WHO-toxic equivalency factors
(WHO-TEFs)) and sum of dioxins and dioxin-like PCBs (sum of PCDDs, PCDFs and polychlorinated biphenyls
(PCBs), expressed as WHO toxic equivalent using the WHO-TEFs). WHO-TEFs for human risk assessment based
on the conclusions of the World Health Organization (WHO) – International Programme on Chemical Safety
(IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World
Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and
Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))
Congener
TEF value
Dibenzo-p-dioxins (‘PCDDs’)
Congener
TEF value
“Dioxin-like” PCBs Non-ortho
PCBs + Mono-ortho PCBs
2,3,7,8-TCDD
1
1,2,3,7,8-PeCDD
1
Non-ortho PCBs
1,2,3,4,7,8-HxCDD
0,1
PCB 77
1,2,3,6,7,8-HxCDD
0,1
PCB 81
0,0003
1,2,3,7,8,9-HxCDD
0,1
PCB 126
0,1
1,2,3,4,6,7,8-HpCDD
0,01
PCB 169
0,03
OCDD
0,0003
Dibenzofurans (‘PCDFs’)
0,0001
Mono-ortho PCBs
2,3,7,8-TCDF
0,1
PCB 105
0,00003
1,2,3,7,8-PeCDF
0,03
PCB 114
0,00003
2,3,4,7,8-PeCDF
0,3
PCB 118
0,00003
1,2,3,4,7,8-HxCDF
0,1
PCB 123
0,00003
1,2,3,6,7,8-HxCDF
0,1
PCB 156
0,00003
1,2,3,7,8,9-HxCDF
0,1
PCB 157
0,00003
2,3,4,6,7,8-HxCDF
0,1
PCB 167
0,00003
1,2,3,4,6,7,8-HpCDF
0,01
PCB 189
0,00003
1,2,3,4,7,8,9-HpCDF
0,01
OCDF
0,0003
Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin;
“CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.’
3.12.2011
EN
Official Journal of the European Union
(c) footnote 33 is replaced by the following:
‘(33) The maximum level expressed on fat is not applicable for foods containing < 2 % fat. For foods containing less
than 2 % fat, the maximum level applicable is the level on product basis corresponding to the level on product
basis for the food containing 2 % fat, calculated from the maximum level established on fat basis, making use of
following formula:
Maximum level expressed on product basis for foods containing less than 2 % fat = maximum level expressed on
fat for that food x 0,02’.
L 320/23